Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE) (NOVICE)

• ClinicalTrials.gov Identifier: NCT03040544
• Recruitment Status: Recruiting
• First Posted: February 2, 2017
• Last Update Posted: May 14, 2020
• Sponsor: University Hospital Schleswig-Holstein
• Information provided by (Responsible Party): Michael Thomschewski, University Hospital Schleswig-Holstein

Study Description

Brief Summary:

Background: Laparoscopic surgical procedures have become increasingly established in operative medicine. They require special motor, haptic, and spatial-visual skills to perform the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills are often learned in the operating room (OR) on the patient. This is economically inefficient and can be improved with regard to patient safety. Against the background of this problem, various simulators and video-box trainer have been developed in order to train laparoscopic basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer including standardized and validated exercises with defined targets, based on the skills of experts MIS. Conducting MIS training outside the OR prior to performing the first MIS procedures on patients could be a sensible and valuable contribution to effective surgical education. An evidence of effectiveness in the practice transfer could have a considerable relevance with regard to the integration of MIS training programs into surgical education programs.

Aim of the study: The aim of the study is to investigate whether surgical residents without previous active experience in MIS are able to improve laparoscopic skills in MIS procedures in the OR, if they have successfully completed the LTB curriculum.

In the multicentric prospective study, will be conducted with surgical residents (SR) without prior active experience in MIS (n=14). After the SR have completed their first laparoscopic cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements in operative performance (between CHE I and CHE II) will be evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).

Condition or disease	Intervention/treatment	Phase
Minimally Invasive Surgery Basic Skills	Procedure: LTB-Curriculum; Procedure: Laparoscopic cholecystectomy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Goal-directed Minimally Invasive Surgery Simulation Training With the Lübeck Toolbox-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)
• Actual Study Start Date: May 22, 2017
• Estimated Primary Completion Date: May 21, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: LTB-Curriculum; First group/arm undergo MIS training according to the LTB curriculum after the first own laparoscopic cholecystectomy in the OR as a baseline. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using the Global Operational Assessment of Laparoscopic Skill (GOALS) score.	Procedure: LTB-Curriculum; The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.; Procedure: Laparoscopic cholecystectomy; Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS
Active Comparator: no LTB-Curriculums; Second group/arm will not undergo any MIS trains after their first laparoscopic CHE in the OR. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using GOALS score.	Procedure: Laparoscopic cholecystectomy; Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

Outcome Measures

Primary Outcome Measures :

1. Global Operative Assessment of Laparoscopic Skill (GOALS)-Score [ Time Frame: end of inclusion of all participants ]
   The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon

Secondary Outcome Measures :

1. operation time [ Time Frame: 8-12 weeks ]
   operation time of CHE I and CHE 2
2. percentage of the participants operating time in the total time of the CHE [ Time Frame: 8-12 weeks ]
   percentage of participants operating time in the total time of the CHE I and CHE II
3. number of takeovers by the specialist assisting the CHE [ Time Frame: 8-12 weeks ]
   experienced consultant surgeon will assist the CHE. The specialist can take over the operation at any time and perform surgical steps independently, according to his/her judgement with regard to the individual situation
4. potential conversion to laparotomy [ Time Frame: 8-12 weeks ]
   potential conversion of the MIS CHE to open surgery

Other Outcome Measures:

1. sex of participant [ Time Frame: 8-12 weeks ]
   sex of participant (male or female)
2. dominant hand of participant [ Time Frame: 8-12 weeks ]
   dominant hand of participant (right or left)
3. age of participant [ Time Frame: 8-12 weeks ]
   age of the participants
4. correlation with activities and hobbies [ Time Frame: 8-12 weeks ]
   in particular playing an instrument, handicrafts and computer games
5. inter-rater reliability [ Time Frame: 8-12 weeks ]
   possible differences and bias between video ratings by calculation

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• no motor or sensory restrictions when using surgical instruments surgical instruments.
• no previous performed MIS simulation training
• no previous performed MIS procedure ( any previous assisted MIS procedures are not an exclusion criterion)
• residents in surgical education for general or visceral surgery in Germany

Exclusion Criteria:

• The participant are not allowed to perform any other MIS training programs during the study period
• Before the start of the study, participants are not allowed to have performed any prior MIS simulation training or any MIS procedure

Contacts and Locations

Contacts

Contact: Michael Thomaschewski, MD; +491784007135; Michael.Thomaschewski@uksh.de

Locations

Germany

Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery; Recruiting

Lubeck, Schleswig-Holstein, Germany, 23538

Contact: Michael Thomaschewski, MD +491784007135 Michael.Thomaschewski@uksh.de

Sponsors and Collaborators

University Hospital Schleswig-Holstein

Investigators

• Study Director: Claudia Benecke, MD; Medical University Center Schleswig-Holstein Campus Lübeck
• Study Director: Tilman Laubert, MD; Medical University Center Schleswig-Holstein Campus Lübeck

More Information

• Responsible Party: Michael Thomschewski, Dr., University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT03040544
• Other Study ID Numbers: NOVICE trial
• First Posted: February 2, 2017
• Last Update Posted: May 14, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Thomschewski, University Hospital Schleswig-Holstein:

minimally invasive surgery; video-based trainer; laparoscopic; simulation training; surgical education